Bipartisan lawmakers in the House and Senate are pressing the Biden administration on MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD).
In a letter to President Biden, retired Marine Corps lieutenant general and current Rep. Jack Bergman (R-Mich.) and 60 other House members called on the administration to follow science and approve a new treatment that uses MDMA – the chemical found in ecstasy or molly – with psychotherapy to treat PTSD.
Bergman is the highest-ranking combat veteran in Congress. A similar letter to Food and Drug Administration (FDA) Commissioner Robert Califf from 19 senators was led by Senators Michael Bennett (D-Colo.) and Thom Tillis (RN.C.).
More than 13 million people in the U.S. live with PTSD, and veterans are disproportionately affected, according to estimates from the National Center on PTSD. But current treatments are notoriously not very effective.
The FDA has not approved any new treatments for PTSD in more than two decades, and lawmakers have said continued high rates of veteran suicides mean the government must do more to protect veterans.
“Despite billions of federal dollars spent on treating PTSD and mental health, the number of veteran lives lost to suicide has not decreased,” the House letter stated. “This is partly due to the fact that the FDA has not approved any new treatments for PTSD in almost 25 years. This surprising lack of innovation has undoubtedly contributed to the rise in veteran suicide rates over the past two decades.”
Lawmakers said the FDA’s own studies show there is significant promise in using psychedelic MDMA therapy to treat veterans suffering from PTSD, but that the FDA needs to follow the evidence.
“The potential for innovative advances in the treatment of PTSD is within our reach, and we owe it to our veterans and other affected populations to review these potentially transformative therapies based on robust clinical and scientific evidence,” the senators wrote.
“If comprehensive evidence demonstrates that MDMA-AT is effective and safe when administered in appropriate settings, it is our responsibility to ensure this treatment option is made available to those who could benefit from it.”
The FDA is expected to decide this week whether to approve Lykos Therapeutics’ application. Supporters have launched a pressure campaign as approval is far from certain.
The agency’s independent advisory board strongly recommended against approval during a meeting in June after raising questions about the integrity of the trial studying the treatment and the lack of safety data. They praised the treatment’s promise, but said the risks far outweighed any benefits, and expressed concern that the manufacturer’s scientific work had been influenced by the psychedelic evangelism of its parent organization, the Multidisciplinary Association for Psychedelic Studies.
The committee voted 9-2 that the data do not show the drug is effective in treating PTSD and 10-1 that the benefits do not outweigh the risks.
The advisory panel’s decisions are not binding, but they carry a lot of weight. The agency has gone against its scientific advisors before, but it’s a rare occurrence.
An FDA rejection of the therapy would deal a major industry-wide blow to the potential of psychedelic drugs as a PTSD treatment.
In the letter to Biden, which was copied to the heads of the Health and Human Services and Veterans Affairs departments, House members addressed outside criticism.
“It is not our intention to pressure the FDA in any direction related to its decision, which should be based solely on data and evidence. However, we are aware that as this application went through the regulatory review process, certain groups and individuals expressed criticism of the application,” they wrote.
“It is our understanding that, although these critics may be well-intentioned, their criticisms do not necessarily reflect science, but rather their personal ideological beliefs and biases related to the medicalization of substances like MDMA.”
This story originally appeared on thehill.com read the full story
